NCT04039074已完成不适用
Effects of Yoga and Relaxation on Stress and Quality of Life - a Three-armed Randomized Controlled Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Stress questionnaire (Cohen Perceived Stress Scale, CPSS)
研究概览
简要总结
The aim of this study is to measure the effects of three stress reduction methods on patients with stress and stress associated complaints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stress with at least 4 of 10 points on the Numeric Analogue Scale (NAS) at least 1 month and at least 3 of the following 8 stress symptoms: sleep disorder, inappetence or increased appetite, shoulder neck tension/back pain, tension headache, concentration disorder, exhaustion, nervousness/irritability, stress-associated digestive problems
排除标准
- •serious acute or chronic diseases
- •pregnancy or lactation
- •known serious mental illness
- •immobility or restriction for gymnastics exercises due to orthopaedic, neurological or other medical cause
- •participation in another study
研究组 & 干预措施
Integrative Yoga
Experimental
A 12-week "Integrative Yoga" intervention which has meditative and psycho-educational components corresponding to traditional yoga practice.
干预措施: Integrative Yoga (Behavioral)
Iyengar yoga
Active Comparator
A 12-week established, predominantly body-oriented yoga intervention (Iyengar yoga).
干预措施: Iyengar Yoga (Behavioral)
Mindfulness
Active Comparator
A 12-week mindfulness intervention designed for the healthy handling of stress.
干预措施: Mindfulness (Behavioral)
结局指标
主要结局
Stress questionnaire (Cohen Perceived Stress Scale, CPSS)
时间窗: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Change from Baseline in the CPSS, range from 0 to 4 in each item. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the positively stated items and then summing across all scale items while higher values meaning a higher grade of perceived stress.
次要结局
- Maslach Burnout Inventory (MBI)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Multidimensional Assessment of Interoceptive Awareness (MAIA)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Zerssen symptom list (B-LR and B-LR')(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Aspects of Spirituality (ASP)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Hospital Anxiety and Depression Scale (HADS)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Self-Regulation(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Evaluation questions(After 12 weeks, after 24 weeks)
- Numerical Analog Scales(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Mysticism Scale Short Form(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Expectation questions(Date of inclusion (baseline))
- Bio-electrical Impedance Analysis (BIA)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Dietary Behaviour assessed by Food Frequency Questionaire (Gesundheit Erwachsener in Deutschland, DEGS)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Heart Rate Variability (HRV)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Medication intake(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Sociodemographic Measurements(Date of inclusion (baseline))
- Behavioral questions: cigarettes(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Electrodermal Activity (Galvanic Skin Response)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Skin Temperature(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Medical Outcomes Study Short Form Quality of Life (MOS SF-36)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- International Physical Activity Questionnaire (IPAQ)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Trauma symptoms (Posttraumatic Checklist, PCL-5)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Blood Volume Pulse(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Respiration Rate(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Heart Rate (HR)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Body Mass Index (kg/m2)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Behavioral questions: relaxation(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Blood Oxygenization(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Behavioral questions: alcohol consumption(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Interbeat Interval (IBI)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Body weight (kg)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Waist circumference (cm)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
研究者
Andreas Michalsen
Prof. Dr. med.
Charite University, Berlin, Germany
研究点 (1)
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